Guardant Health, AstraZeneca partner to develop companion diagnostics tests

Guardant Health (GH) announced a multi-year agreement with AstraZeneca (AZN) to develop blood-based companion diagnostic tests supporting the commercialization of AstraZeneca’s oncology portfolio based on Guardant’s industry-leading comprehensive liquid biopsy platform.Under the terms of the agreement, Guardant Health will develop and pursue FDA approval for a Guardant360 CDx test for Tagrisso, AstraZeneca’s best-in-class, third-generation EGFR inhibitor in advanced non small cell lung cancer. Use of this assay will help identify patients that may respond to Tagrisso via a minimally-invasive blood test.Guardant Health will also develop a plasma-based tumor mutational burden score CDx test using GuardantOMNI to predict response to AstraZeneca immunotherapy and targeted therapies within its oncology portfolio. AstraZeneca presented TMB data using this device from the Phase III MYSTIC trial at the European Society for Medical Oncology Immuno-Oncology 2018 Congress. The US Food and Drug Administration has granted breakthrough designation to the GuardantOMNI diagnostic device for its proprietary plasma-based TMB score. The Guardant TMB scoring methodology is optimized for plasma-based testing by accounting for several factors, including tumor shedding, to maximize sensitivity and specificity. The agreement allows for development of further liquid biopsy CDx tests for AstraZeneca’s other clinical development programs.
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